Single-Use Video Bronchoscopes, Digital Controller

Bronchoscope (flexible Or Rigid)

Micro-Tech (Nanjing) Co., Lts

The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Lts with the FDA for Single-use Video Bronchoscopes, Digital Controller.

Pre-market Notification Details

Device IDK213782
510k NumberK213782
Device Name:Single-Use Video Bronchoscopes, Digital Controller
ClassificationBronchoscope (flexible Or Rigid)
Applicant Micro-Tech (Nanjing) Co., Lts No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone Nanjing,  CN 210032
ContactSally He
CorrespondentSally He
Micro-Tech (Nanjing) Co., Lts No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone Nanjing,  CN 210032
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-03
Decision Date2022-07-08

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